Starkey
449 catalogue numbers from Starkey Omega AI 16 HS R, listed by Starkey Laboratories, Inc., United States, under Masker, Tinnitus. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
449catalogue numbers in this listing
10510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (3), Fujian (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GN Resound China, Ltd. | Xiamen | Fujian | Contract manufacturer | 7 |
| Sonova Hearing (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 3 |
| Jiangsu Betterlife Medical Co., Ltd. | Jiangsu | Jiangsu | Manufacturer | 4 |
| Starkey (Suzhou) Hearing Technology Co., Ltd. | Guoxiang, Wuzhong District, Suzhou | Jiangsu | Manufacturer | 3 |
Record
| Listed by | Starkey Laboratories, Inc., United States |
|---|---|
| FDA product code | KLW |
| Device type | Masker, Tinnitus |
| Device class | Class 2 |
| Regulation | 21 CFR 874.3400 |
| Establishment | Manufacturer |
| Record published | 2025-08-27 |
| Record revised | 2025-08-20 (version 5) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment humidity 10 to 95 % RH; Storage environment temperature -40 to 60 °C |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Starkey Omega AI 16 HS R | In distribution | |
| STARKEY EVOLV AI 1200 ITE R | In distribution | |
| MUSE 2000 BTE 312 | In distribution | |
| MUSE IQ I2400 BTE 13 | In distribution | |
| MUSE IQ CROSBICROS BTE 13 | In distribution | |
| STARKEY EVOLV AI 1000 CIC NW | In distribution | |
| HALO 2 I1000 RIC 13 | In distribution | |
| MUSE IQ 1000 MRIC 312 | In distribution | |
| MUSE 2400 ITE | In distribution | |
| STARKEY EVOLV AI POWER PLUS BTE 13 | In distribution | |
| MUSE IQ 1200 RIC 312 | In distribution | |
| STARKEY LIVIO AI 1000 BTE 13 | In distribution | |
| STARKEY GENESIS AI 24 IIC NW | In distribution | |
| XINO I20 MRIC 312 | In distribution | |
| STARKEY EDGE AI CROS RIC 312 | In distribution | |
| STARKEY EVOLV AI 1000 MRIC 312 | In distribution | |
| STARKEY EDGE AI 24 CIC | In distribution | |
| STARKEY EVOLV AI CROS RIC R | In distribution | |
| MUSE IQ I1000 RIC 312 | In distribution | |
| SOUNDLENS SYNERGY 1600 IIC | In distribution | |
| MUSE IQ I1600 BTE 312 | In distribution | |
| STARKEY LIVIO 1000 RIC 312 | In distribution | |
| STARKEY LIVIO 1600 ITE R | In distribution | |
| MUSE IQ I1000 BTE 13 PWRPLS | In distribution | |
| MUSE 1200 MRIC 312 | In distribution | |
| STARKEY GENESIS AI 24 RIC 312 | In distribution | |
| SOUNDLENS SYN IQ I1200 IIC | In distribution | |
| STARKEY LIVIO 1200 RIC 312 | In distribution | |
| STARKEY PICASSO 2400 CIC | In distribution | |
| STARKEY LIVIO AI 1200 HS R | In distribution | |
| STARKEY GENESIS AI 20 IIC NW | In distribution | |
| Starkey Omega AI 24 mRIC R (GS DEMO) | In distribution | |
| MUSE 1200 BTE 13 PWRPLS | In distribution | |
| STARKEY LIVIO 1000 BTE 13 | In distribution | |
| STARKEY PICASSO I1200 ITC | In distribution | |
| STARKEY LIVIO AI 1600 ITE R | In distribution | |
| MUSE 2000 BTE 312 | In distribution | |
| MUSE IQ 1600 BTE 13 | In distribution | |
| Muse i2000 BTE 13 | In distribution | |
| MUSE IQ 1600 ITE | In distribution | |
| Muse i1200 BTE 13 | In distribution | |
| STARKEY LIVIO AI 1600 RIC 312 | In distribution | |
| STARKEY EDGE AI RIC 312 | In distribution | |
| STARKEY EDGE AI 20 RIC RT | In distribution | |
| STARKEY PICASSO I1200 CIC | In distribution | |
| STARKEY LIVIO 1200 BTE R | In distribution | |
| MUSE CROSBICROS ITE | In distribution | |
| EVOLV AI CROS RIC R (GS) | In distribution | |
| STARKEY EDGE AI 16 CIC | In distribution | |
| SOUNDLENS SYN IQ 1200 IIC | In distribution | |
| STARKEY LIVIO AI 1200 BTE 13 | In distribution | |
| MUSE 1200 BTE 13 PWRPLS | In distribution | |
| MUSE 1000 MRIC 312 | In distribution | |
| MUSE I1600 RIC 312t | In distribution | |
| MUSE I1000 ITE | In distribution | |
| Starkey Omega AI 16 ITC R | In distribution | |
| STARKEY LIVIO 1200 BTE 13 | In distribution | |
| STARKEY LIVIO 1200 RIC 312 | In distribution | |
| STARKEY LIVIO AI CROSBICROS BTE 13 | In distribution | |
| EVOLV AI HS R | In distribution | |
| MUSE CROSBICROS MRIC 312 | In distribution | |
| STARKEY LIVIO AI 1200 RIC R | In distribution | |
| STARKEY EVOLV AI 2400 CIC NW | In distribution | |
| STARKEY LIVIO 2400 RIC 312 | In distribution | |
| STARKEY LIVIO EDGE AI CROSBICROS RIC 312 | In distribution | |
| HALO 2 I2400 RIC 312 | In distribution | |
| MUSE CROSBICROS HALF SHELL | In distribution | |
| MUSE IQ I2400 HALF SHELL | In distribution | |
| Starkey Omega AI 24 ITE R | In distribution | |
| STARKEY LIVIO 1200 RIC 312 | In distribution | |
| MUSE IQ 1200 MRIC 312R | In distribution | |
| MUSE IQ I1200 ITE | In distribution | |
| STARKEY LIVIO 2400 RIC 312 | In distribution | |
| STARKEY LIVIO AI 2000 RIC 312 | In distribution | |
| XINO I70 MRIC 312 | In distribution | |
| MUSE IQ 2000 BTE 13 PWRPLS | In distribution | |
| STARKEY LIVIO 2000 RIC 312 | In distribution | |
| STARKEY EDGE AI 16 ITC R | In distribution | |
| STARKEY EVOLV AI 1000 RIC R | In distribution | |
| Starkey G Series AI 16 UP BTE 13 | In distribution | |
| MUSE 2000 HALF SHELL | In distribution | |
| Starkey G Series AI 12 RIC R | In distribution | |
| MUSE I1600 CIC | In distribution | |
| STARKEY LIVIO 2000 ITC R | In distribution | |
| MUSE 1600 BTE 13 PWRPLS | In distribution | |
| Muse 2400 BTE 13 | In distribution | |
| MUSE IQ 2400 BTE 13 PWRPLS | In distribution | |
| STARKEY PICASSO 1600 IIC | In distribution | |
| STARKEY GENESIS AI 16 ITC R | In distribution | |
| Starkey Omega AI RIC RT (TIER DEMO) | In distribution | |
| Muse i1600 mRIC 312t | In distribution | |
| STARKEY PICASSO I1000 CIC | In distribution | |
| STARKEY EVOLV AI 1000 CIC | In distribution | |
| EVOLV AI ITC R | In distribution | |
| STARKEY LIVIO AI 1000 HS R | In distribution | |
| STARKEY EVOLV AI 2000 POWER PLUS BTE 13 (PL) | In distribution | |
| STARKEY LIVIO 1000A RIC R | In distribution | |
| STARKEY EVOLV AI 2400 RIC 312 | In distribution | |
| STARKEY EVOLV AI 1200 MRIC 312 | In distribution | |
| EVOLV AI CROS RIC 312 (GS) | In distribution | |
| STARKEY GENESIS AI 16 CIC 312 | In distribution | |
| STARKEY EVOLV AI CROS BTE 13 | In distribution | |
| MUSE IQ 1200 BTE 13 | In distribution | |
| STARKEY EVOLV AI 2000 IIC NW | In distribution | |
| STARKEY LIVIO 2400 BTE 13 | In distribution | |
| MUSE 1200 HALF SHELL | In distribution | |
| STARKEY LIVIO 1200 MRIC 312 | In distribution | |
| MUSE CROSBICROS BTE 13 | In distribution | |
| MUSE IQ 2400 BTE 13 | In distribution | |
| MUSE 1600 RIC 312t | In distribution | |
| SOUNDLENS SYN IQ 2400 IIC | In distribution | |
| Muse i1000 PL BTE 13 | In distribution | |
| MUSE IQ I1000 CIC | In distribution | |
| MUSE IQ I1200 BTE 13 | In distribution | |
| STARKEY LIVIO 2400 ITE R | In distribution | |
| MUSE 2400 HALF SHELL | In distribution | |
| MUSE IQ I2000 RIC R | In distribution | |
| MUSE IQ I1200 BTE 312 | In distribution | |
| STARKEY GENESIS AI 24 MRIC R (DEMO) | In distribution | |
| MUSE IQ 2000 BTE 312 | In distribution | |
| MUSE I1200 RIC 312t | In distribution | |
| STARKEY EDGE AI 12 ITC R | In distribution | |
| STARKEY LIVIO AI 2400 BTE 13 | In distribution | |
| STARKEY LIVIO CROSBICROS RIC R | In distribution | |
| Muse i1600 PL BTE 13 | In distribution | |
| MUSE I2400 CIC | In distribution | |
| STARKEY LIVIO AI 2000 MRIC 312 | In distribution | |
| HALO IQ I1200 RIC 13 | In distribution | |
| STARKEY LIVIO AI 1600 MRIC 312 | In distribution | |
| STARKEY GENESIS AI 24 RIC RT (SCIF) (DEMO) (SCIF GS) | In distribution | |
| STARKEY EDGE AI 24 RIC 312 (VA DEMO) | In distribution | |
| MUSE IQ I1600 ITC | In distribution | |
| MUSE CROS RIC 312t | In distribution | |
| STARKEY GENESIS AI CROSBICROS RIC 312 (GS) | In distribution | |
| HALO IQ I1600 RIC 312 | In distribution | |
| STARKEY LIVIO AI 1000 RIC R | In distribution | |
| Starkey Omega AI 20 CIC | In distribution | |
| STARKEY LIVIO 2400 HS R | In distribution | |
| STARKEY LIVIO 1000A BTE 13 | In distribution | |
| MUSE IQ I1200 BTE 312 | In distribution | |
| STARKEY LIVIO EDGE AI 2400 BTE R | In distribution | |
| STARKEY EVOLV AI BTE R | In distribution | |
| STARKEY PICASSO 1600 ITC | In distribution | |
| STARKEY LIVIO AI CROSBICROS BTE 13 | In distribution | |
| STARKEY EVOLV AI 1200 POWER PLUS BTE 13 | In distribution | |
| MUSE IQ I1600 RIC R | In distribution | |
| STARKEY LIVIO 1000 RIC 312 | In distribution | |
| STARKEY PICASSO I2400 ITC | In distribution | |
| STARKEY LIVIO 1200 RIC R | In distribution | |
| STARKEY LIVIO AI 1600 RIC R | In distribution | |
| MUSE IQ 1200 HALF SHELL | In distribution | |
| STARKEY EVOLV AI 1600 RIC 312 | In distribution | |
| STARKEY EDGE AI 20 ITE R | In distribution | |
| STARKEY LIVIO AI 1000 RIC 312 | In distribution | |
| MUSE I1000 RIC 312t | In distribution | |
| STARKEY LIVIO 1600 BTE 13 | In distribution | |
| Starkey Omega AI 24 RIC RT (DEMO) | In distribution | |
| MUSE IQ 1600 RIC 312 | In distribution | |
| MUSE IQ 1600 ITC | In distribution | |
| MUSE CROSBICROS BTE 312 | In distribution | |
| MUSE 2400 MRIC 312 | In distribution | |
| MUSE I1200 CIC | In distribution | |
| STARKEY LIVIO AI 1000 ITE R | In distribution | |
| STARKEY EDGE AI 24 MRIC R | In distribution | |
| Muse i2400 PL BTE 13 | In distribution | |
| MUSE IQ I1200 RIC 312 | In distribution | |
| MUSE IQ 2400 MRIC 312R | In distribution | |
| MUSE I2400 BTE 312 | In distribution | |
| MUSE IQ I1000 RIC R | In distribution | |
| STARKEY EVOLV AI 1600 RIC R | In distribution | |
| MUSE IQ 1000 MRIC 312 | In distribution | |
| INSPIRE X 2018.1 USB CARD | In distribution | |
| XINO TINNITUS 90 RIC 10 | In distribution | |
| SOUNDLENS SYNERGY 2400 IIC | In distribution | |
| HALO 2 I1000 RIC 312R | In distribution | |
| STARKEY GENESIS AI 24 RIC RT | In distribution | |
| MUSE IQ I1600 RIC R | In distribution | |
| HALO IQ I1000 RIC 13 | In distribution | |
| STARKEY LIVIO 2000 MRIC 312 | In distribution | |
| MUSE 1600 ITC | In distribution | |
| MUSE IQ I1200 BTE 13 PWRPLS | In distribution | |
| MUSE IQ CROSBICROS BTE 13 | In distribution | |
| STARKEY EVOLV AI 1600 BTE R | In distribution | |
| STARKEY LIVIO AI RIC R | In distribution | |
| XINO I30 MRIC 312 | In distribution | |
| MUSE I2400 MRIC 312 | In distribution | |
| MUSE IQ CROSBICROS RIC 312 | In distribution | |
| MUSE I1600 ITC | In distribution | |
| Starkey Omega AI 16 ITE R | In distribution | |
| STARKEY LIVIO AI 2400 RIC R | In distribution | |
| STARKEY LIVIO AI 1000 RIC 312 | In distribution | |
| STARKEY EDGE AI 24 MRIC R (VA TIER DEMO) | In distribution | |
| HALO 2 I2000 RIC 13 | In distribution | |
| MUSE I2000 BTE 312 | In distribution | |
| MUSE I1000 BTE 13 PWRPLS | In distribution | |
| STARKEY LIVIO EDGE AI 2400 ITE R | In distribution | |
| STARKEY LIVIO AI 1000 RIC R | In distribution | |
| STARKEY LIVIO AI RIC R | In distribution | |
| STARKEY PICASSO 2000 ITC | In distribution | |
| STARKEY GENESIS AI 24 CIC NW (GS) | In distribution | |
| MUSE I2400 ITE | In distribution | |
| STARKEY LIVIO 2000 BTE 13 | In distribution | |
| MUSE 2000 ITC | In distribution | |
| STARKEY EVOLV AI 1000 BTE 13 | In distribution | |
| MUSE IQ I1600 BTE 312 | In distribution | |
| STARKEY LIVIO EDGE AI CROSBICROS RIC R | In distribution | |
| MUSE IQ I1000 MRIC 312R | In distribution | |
| STARKEY LIVIO 2000 RIC 312 | In distribution | |
| STARKEY EDGE AI 16 RIC RT | In distribution | |
| MUSE 2400 BTE 312 | In distribution | |
| STARKEY LIVIO RIC 312 | In distribution | |
| STARKEY MODEL S 2 BTE 13 | In distribution | |
| Starkey Omega AI RIC RT (GS DEMO) | In distribution | |
| HALO 2 IQ I2400 RIC 312R | In distribution | |
| STARKEY LIVIO AI 1200 RIC 312 | In distribution | |
| MUSE IQ 1600 MRIC 312 | In distribution | |
| STARKEY LIVIO AI 1600 BTE 13 | In distribution | |
| MUSE I2400 ITC | In distribution | |
| STARKEY LIVIO AI 1600 MRIC 312 | In distribution | |
| Thrive Hearing Control for iOS | In distribution | |
| MUSE IQ I2400 BTE 13 PWRPLS | In distribution | |
| STARKEY LIVIO 2400 ITC R | In distribution | |
| STARKEY EVOLV AI 2000 ITC R | In distribution | |
| MUSE I1600 CIC | In distribution | |
| MUSE 1000 RIC 312t | In distribution | |
| STARKEY PICASSO 2000 IIC | In distribution | |
| MUSE IQ I2400 BTE 312 | In distribution | |
| MUSE IQ 1000 BTE 13 PWRPLS | In distribution | |
| MUSE IQ I2000 RIC 312 | In distribution | |
| STARKEY LIVIO 2000 ITE R | In distribution | |
| MUSE I1600 MRIC 312 | In distribution | |
| STARKEY GENESIS AI 24 RIC RT (SCIF) (DEMO) | In distribution | |
| MUSE IQ I1000 BTE 13 | In distribution | |
| Muse 2400 PL BTE 13 | In distribution | |
| MUSE I2000 BTE 312 | In distribution | |
| MUSE IQ I1600 ITE | In distribution | |
| MUSE 2400 RIC 312t | In distribution | |
| STARKEY GENESIS AI 12 CIC 312 | In distribution | |
| EVOLV AI ITE R | In distribution | |
| STARKEY MODEL S 3 BTE 13 | In distribution | |
| MUSE IQ 1600 BTE 13 | In distribution | |
| HALO 2 I1000 RIC 312R | In distribution | |
| MUSE IQ 1600 MRIC 312R | In distribution | |
| MUSE IQ 1200 BTE 312 | In distribution | |
| STARKEY LIVIO 2400 RIC 312 | In distribution | |
| MUSE IQ I1000 HALF SHELL | In distribution | |
| STARKEY PICASSO 1600 CIC | In distribution | |
| STARKEY PICASSO 1600 HALF SHELL | In distribution | |
| MUSE IQ I1600 MRIC 312R | In distribution | |
| STARKEY LIVIO EDGE AI CROSBICROS BTE 13 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Oticon | Sbo Hearing A/S | 570 |
| Phonak | Sonova AG | 448 |
| Oticon | Oticon A/S | 353 |
| Nuear | Starkey Laboratories, Inc. | 336 |
| Audibel | Starkey Laboratories, Inc. | 318 |
| Unitron | Unitron Hearing Division | 292 |
| Audigy | Starkey Laboratories, Inc. | 284 |
| Microtech | Starkey Laboratories, Inc. | 284 |
| audifon | Audifon – Gmbh & Co.kg | 277 |
| Philips | Sbo Hearing A/S | 270 |
| Agxo | Sbo Hearing A/S | 260 |
| Hansaton | Hansaton Akustik GmbH | 249 |
Showing 12 of 86. All products under Masker, Tinnitus
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K201370 | 2020-06-19 |
| K122876 | 2012-10-31 |
| K030180 | 2003-09-17 |
| K964216 | 1996-12-06 |
| K963838 | 1996-11-26 |
| K963995 | 1996-11-26 |
| K791790 | 1979-10-26 |
| K791142 | 1979-09-28 |
| K791071 | 1979-07-03 |
| K781798 | 1978-11-03 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.